Regulatory Enforcement Action Support

FDA Form 483

Overview

Why Work With NSF?

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and applicable regulations and requirements. It is important that companies take 483 observations seriously and respond to them in an appropriate and timely manner.

Responses to 483s need to be carefully crafted to reflect a firm’s understanding and commitment to remedy the objectionable observations in a holistic manner that focuses on the entire system rather than on the specific observation. The 483 is not inclusive of all objectionable conditions, but reflects only what was noted during that particular inspection. Companies are therefore encouraged to take the opportunity to assess their quality system as a whole and address any gaps present beyond those noted on the 483.

NSF Pharma Biotech experts have been part of the regulatory authority and industry for decades. They can offer unique insights into the 483 observations and help your company draft communication to the FDA and take the necessary corrective actions to remediate objectionable conditions.

For more information about NSF Pharma Biotech regulatory enforcement action support in the U.S., email uspharma@nsf.org or call +1 202.822.1850.

Why Work With NSF?

Our team includes former U.S. FDA inspectors and experts with decades of experience helping companies develop strategic plans to address and to respond to FDA 483s. Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.